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February 14, 2022

Nykode concludes subject enrolment in Phase II cervical cancer vaccine trial

The multicentre, open-label trial enrolled subjects with advanced or recurrent, non-resectable HPV16-positive cervical cancer.

Nykode Therapeutics has concluded the subject enrolment in the Phase II VB C-02 clinical trial of its cancer vaccine candidate, VB10.16, plus atezolizumab to treat advanced cervical cancer. 

Interim efficacy and safety results from the trial are anticipated in the first half of this year.

An off-the-shelf therapeutic HPV16 cancer vaccine, VB10.16 can potentially elicit robust human papillomavirus 16 (HPV16)-specific T cell responses to treat cancers that are positive for HPV16.

Atezolizumab is a checkpoint inhibitor of Roche.

The multicentre, open-label trial enrolled advanced or recurrent, non-resectable HPV16-positive cervical cancer patients. 

Nealy 20 study centres have enrolled 50 participants in six European countries as part of the trial. 

Earlier, the company had reported positive interim safety results from this trial.

Nykode Therapeutics CEO Michael Engsig said: “After successfully enrolling 50 patients across trial sites in six countries, we look forward to reporting interim efficacy and safety data from the first patients in the first half of 2022. 

“In parallel, we are exploring the possibility of evaluating VB10.16 in other HPV-driven cancers, including head and neck cancer.”

Apart from the VB10.16 vaccine, the company has a cancer neoantigen vaccine, VB10.NEO.

Licensed exclusively to Genentech, VB10.NEO is currently being analysed in Phase Ib trial to treat locally advanced and metastatic tumours, as well as a Phase I/IIa trial to treat melanoma, lung, head and neck, renal and bladder cancers. 

Nykode commenced a Phase I/II trial of its two Covid-19 vaccine candidates last year.

Last December, the company dosed the first subject in Phase I/II VB-D-01 trial of its T cell-specific Covid-19 vaccine candidate in unvaccinated individuals.

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